AzTrials
AzTrials

Ovarian CancerPhase 2NCT00086892

Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase 2 study testing cetuximab and carboplatin in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 76 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
cetuximab and carboplatin
How many people
Not given
Where
76 sitesin 5 countries
Study dates
Jun 2004to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer
  • Recurrent disease
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
  • Target lesion not within previously irradiated field
  • Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
  • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel
  • Platinum-sensitive disease
  • Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen
  • If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol* NOTE: *Applies whether or not both protocols are available at the same participating center
  • Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No uncontrolled arrhythmias within the past 6 months
  • No other significant cardiac disease

Neurologic

  • No uncontrolled seizure disorder
  • No active neurological disease
  • No neuropathy > grade 1

Other

  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
  • No prior chimerized or murine monoclonal antibody therapy
  • At least 3 weeks since prior biologic or immunologic therapy for the malignancy

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow-bearing areas

Surgery

  • More than 30 days since prior major surgery and recovered
  • Diagnostic biopsy not considered major surgery

Other

  • At least 3 weeks since other prior therapy for the malignancy
  • No prior tyrosine kinase inhibitors that target the EGFR pathway
  • No prior cancer treatment that would preclude study treatment
  • No other concurrent investigational agents

Trial locations and contacts

76 sites in 5 countries.

76 sites in 5 countries

United States72 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

    Burlington, Vermont, 05401

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7570

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612-3824

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0520

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44124

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9032

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Central Illinois

    Decatur, Illinois, 62794-9640

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27858

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Study site

    Hinsdale, Illinois, 60521

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1740

  • Women's Cancer Center - Los Gatos

    Los Gatos, California, 95032

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6188

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-2516

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8028

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11790-7775

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01605-2982

Other trials in United States

Australia1 site

  • Australia New Zealand Gynaecological Oncology Trials Group

    Camperdown, New South Wales, 1450

Other trials in Australia

Canada1 site

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

Other trials in Canada

Japan1 site

  • Kagoshima City Hospital

    Kagoshima, 892-8580

Other trials in Japan

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Being tested
cetuximab, carboplatin
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086892
Sponsor's protocol ID
GOG-0146P
Other IDs
BMS-CA225-019, CDR0000371712
Status last verified
Feb 2014
First submitted
8 Jul 2004
Last updated
14 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Secord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14.

    PubMed 18191993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and carboplatin in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 76 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Australia, Canada, Japan, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086892, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in